Thrombectomy catheter and system

ABSTRACT

Cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

CROSS REFERENCES TO CO-PENDING APPLICATIONS

This patent application is a divisional of Ser. No. 09/417,395 filedOct. 13, 1999 now U.S. Pat. No. 6,676,627, which is acontinuation-in-part of Ser. No. 08/349,665 filed Dec. 5, 1994 now U.S.Pat. No. 6,558,366, which is a divisional of Ser. No. 08/006,076 filedJan. 15, 1993, Pat. No. 5,370,609, which is a continuation of Ser. No.07/563,313 filed Aug. 6, 1990, abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to apparatus for use in treatment of thehuman body. More particularly, the present invention relates to anelongated device which may be a single catheter assembly or a multiplecomponent catheter assembly and which is suitable for use throughpercutaneous or other access, for endoscopic procedures, or forintraoperative use in either open or limited access surgical procedures.Still more particularly, the present invention relates to an elongateddevice in the form of a waterjet thrombectomy catheter, hereinaftertermed cross stream thrombectomy catheter, for fragmentation and removalof thrombus or other unwanted material from blood vessels or bodycavities that uses high velocity saline (or other suitable fluid) jetsto macerate the thrombus or other unwanted material. The elongateddevice bears certain similarities to known waterjet thrombectomycatheter constructions but differs therefrom in several materialrespects, a major distinction being in the provision of means whichproduce cross stream jets to create a recirculation flow patternoptimized for clearing a large cross section of mural thrombus or othersimilar material, the name cross stream thrombectomy catheter derivingfrom this major distinction. Further, the present invention also relatesto a system constituted either by the combination of the elongateddevice with both pressurized fluid source means and exhaust regulationmeans or by the combination of the elongated device with onlypressurized fluid source means.

2. Description of the Prior Art

Waterjet thrombectomy catheters have been described in which adistal-to-proximal-directed waterjet(s) flow(s) past a window, orificeor gap at the distal end of the catheter, reentering the catheter andpushing flow through an evacuation lumen. When placed in a vesselcontaining thrombus and activated, the high velocity jet(s) will entrainsurrounding fluid and thrombus into the window, orifice or gap region,where the high shear forces of the jet(s) will macerate the thrombus.The macerated particles will be removed from the body by the pressuregenerated on the distal end of the evacuation lumen by the impingementof the high velocity waterjet(s).

A limitation of these waterjet thrombectomy catheters has been theinability to remove organized, wall-adherent thrombus from largevessels. In accordance with the present invention, a cross streamthrombectomy catheter is described which overcomes this limitation byoptimizing the recirculation pattern at the tip of the catheter toincrease the drag force exerted on the mural thrombus to break it freefrom the vessel wall and allow it to be removed by the catheter.

SUMMARY OF THE INVENTION

The thrombectomy effect of waterjet thrombectomy catheters has beendescribed as using the Venturi effect to create suction at the tip ofthe catheter to draw thrombus into the waterjets where it is thenmacerated and evacuated through an exhaust lumen. However, whenoperating in a relatively large blood vessel, the fluid velocities inthe vessel decrease rapidly as the distance from the jet increases, sothat at the wall of the vessel there is a minimal amount of pressuregradient to push the thrombus towards the low pressure area of thecatheter. Thus, a different force is needed to remove mural thrombus,and that source is fluid drag. Drag on a surface is proportionate to thevelocity gradient at that surface. Thus, in order to maximize the dragforce, the velocity gradient at the surface must be maximized.

The catheter described herein is provided with outflow means and inflowmeans and is designed to optimize the drag force on the surface of thevessel by synergistically utilizing inflows and outflows at the cathetertip to create a recirculation pattern. Since the blood vessel can beconsidered as an open system, the geometric arrangement of the outflowmeans and inflow means is critical to the maximization of the drag forceat the wall of the vessel. Since the catheter is designed to be easilyadvanced axially through a blood vessel, and axial flows are more likelyto dissipate before contributing greatly to recirculation, the flowvectors in the recirculation most important for creating efficientthrombectomy are in the circumferential and radial direction. Radialhigh velocity flow vectors are created by maximizing the flow throughone or more outflow orifices where the one or more outflow orifices aredesigned to aim the flow perpendicular to the axis of the catheter.Circumferential high velocity flow vectors are created by the demand forentrained fluid by one or more inflow orifices and are suppliedsubstantially from the one or more outflow orifices, with change influid flow direction near the vessel wall to return to the catheter.

In the preferred embodiment of the catheter, there is provided inflowmeans in the form of one or more inflow orifices located in an exhausttubular means adjacent and proximal to a jet emanator means in the formof a toroidal loop jet emanator located distally on a jet body. One ormore high velocity saline (or other suitable fluid) jets emanate fromthe toroidal loop jet emanator; these high velocity jet(s) entrainfluid, drawing flow into the inflow orifices, and can macerate thrombusdrawn near the jet(s). One or more of the high velocity jets can beoriented to aid in the exhaust of macerated thrombotic material throughthe exhaust tubular means. Multiple inflow orifices may be formed aroundthe circumference of the exhaust tubular means in a single axial plane.An oval-shaped inflow orifice in which the major axis lies parallel tothe axis of the catheter is preferred to offer an inflow orifice aslarge as possible without compromising the area for inflow and thestructure of the exhaust tubular means. There is also provided outflowmeans in the form of one or more outflow orifices located in the exhausttubular means near the one or more inflow orifices. Multiple outfloworifices may be formed around the circumference of the exhaust tubularmeans in a single axial plane. Preferably, the outflow orifice(s) arelocated proximal to the inflow orifice(s). The outflow orifice(s) areusually located but not are limited to being located in close proximityto the inflow orifice(s). The size and quantity of the outflow orificesare determined to maximize the momentum leaving the outflow orificeswhile not compromising the structural integrity of the exhaust tubularmeans. The high velocity jets and entrained fluid create an internalpressure near the tip of the catheter. This internal pressure ispartially “vented” by the outflow orifice(s). Too small of an area ofthe outflow orifice(s) will minimize the outflow flow rate and riskplugging of the orifice(s) by macerated thrombotic material, whereas toolarge of an outflow area will weaken the radial flow vector of theoutflow and may reduce the ability of the catheter to exhaust themacerated thrombotic material by allowing the internal pressure at thetip to be reduced to the point that there is no driving force for theexhaust. An alternative embodiment can be made in which outflow andinflow orifices are located in the same axial plane, where the directionof flow through the orifices is determined by fluid mechanical factors,e.g., non-symmetric distributions of jets near the orifices. Whilesingle inflow and outflow orifices (or a combination inflow/outfloworifice) can be used, having multiple inflow and outflow orifices helpsto create effective recirculation on all sides of the catheter, avoidingthe problem of having a single orifice blocked by the vessel wall orbeing oriented away from the deposit.

Though not required for most applications, isolation means can beutilized, either incorporated into the catheter, or as a separatedevice, to isolate the portion of the blood vessel near the catheter tipduring use. Isolation means can include balloons, filters, baskets,membranes, blood pressure modification, fluid flow control, or otherocclusion devices such as are known in the art. Isolation means canlimit passage of debris in the blood vessel, limit the flow of blood inthe area of the catheter, or confine the recirculation area near thecatheter tip.

The preferred operation mode of the device is such that the exhaust isregulated to be equivalent to the flow rate of the high velocity salinesupply. Another embodiment of the device can be one in which no exhaustis designed in the catheter, so that it becomes one that macerates thethrombus into particles small enough to pass through the distalvasculature without significant blockage.

The preferred embodiment of the catheter also uses a radio-opaque markercoil aligned in a tapered and flexible tip assembly welded or otherwisesuitably attached to the toroidal loop jet emanator at the distal end ofthe jet body. The radio-opaque marker coil is imbedded in the wall ofthe tapered and flexible tip in alignment with an exhaust lumen in theexhaust tubular means to provide structural integrity to the device sothat the orientation of the jet(s) with respect to the inflow orifice(s)remains constant as the device is advanced and torqued in the anatomy.This tapered flexible radio-opaque marker coil tip can also be used as aflexible base in which a preferentially shaped tip can be mechanicallyor adhesively affixed so as to produce an atraumatic tip which couldalso aid in tracking and insertion.

Alternative embodiments of the present invention include jet emanatormeans having jet orifice(s) in a formed tubular passage, but the tubularpassage is not formed into a toroidal loop as in the preferredembodiment. The formed tubular passage can be a metal tube bent into a“J”, “L” or “U” shape, or a manifold or other chamber with at least oneorifice through which fluid emanates as jet(s). The key features ofinflow orifice(s) through which fluid passes as it is entrained by thejet(s), and the outflow orifice(s) through which some of this entrainedfluid flows, provides non-axial flow for increased recirculation, anddrag again provides enhanced thrombus removal.

One significant aspect and feature of the present invention is athrombectomy catheter having cross stream from one or more outfloworifices for recirculating, creating normal and drag forces, anddisplacing the thrombus off the vessel wall and into one or more infloworifices and having high velocity jets for macerating the thrombus.

Another significant aspect and feature of the present invention is theflow of the outflow jet(s) in a radial direction followed bycircumferential flow whereupon which entrained thrombotic particlesenter the inflow orifice(s) to be further macerated and exhaustedthrough an exhaust lumen.

An optional feature of the present invention is a tapered and flexibletube assembly secured to a toroidal loop jet emanator at one end of ahypo-tube to maintain orientation of a jetted solution in an exhaustlumen and with respect to the inflow orifice(s) as the device isadvanced and torqued in the anatomy.

Another significant aspect and feature of the present invention is theentrainment of fluid by the high velocity jet(s) through one or moreinflow orifices providing a source of additional flow and a localizedregion of higher pressure for driving flow outward through one or moreoutflow orifices. This flow, and the associated recirculation and dragforces, provide a synergistic effect which greatly increases theeffectiveness of the device over what would be expected without the flowrecirculation.

Another significant aspect and feature of the present invention is thatthe aforementioned flow via the outflow orifice(s) provides the enhancedeffectiveness without the need for complicated, expensive, or spaceconsuming additional components, tubings or passageways. The enhancedeffectiveness resulting from inflow and outflow orifices, improvedrecirculation, and vessel wall drag can extend the useful range of thedevice; the greatly enhanced ability to remove blood vessel deposits canallow lower source pressures to be used than otherwise would berequired; and improved function provides for useful application inlarger vessels or cavities than would otherwise be practical, even witha small, flexible catheter.

Another significant aspect and feature of the present invention is thatrecirculation via the inflow orifice(s) provides improved functionwithout damage to the vessel wall which could be caused by a largeopening adjacent the jet(s) allowing the vessel wall to be pulled intothe large opening. The device offers enhanced effectiveness withoutsignificant trauma to the vessel wall, even when operated at highpressures, with 10,000 cm/s to 25,000 cm/s jet velocities, for example.

Having thus described embodiments of the present invention, it is theprincipal object of the present invention to provide a cross streamthrombectomy catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects of the present invention and many of the attendantadvantages of the present invention will be readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanyingdrawings, in which like reference numerals designate like partsthroughout the figures thereof and wherein:

FIG. 1A illustrates in block diagram form a cross stream thrombectomycatheter system according to one embodiment of the present inventionshowing the interrelation of the various functional means thereof;

FIG. 1B illustrates a side view of an elongated device in the from of across stream thrombectomy catheter with provision for exhaust;

FIG. 2 illustrates an exploded view in cross section of the distal endof the cross stream thrombectomy catheter;

FIG. 3 illustrates an assembled view in cross section of the distal endof the cross stream thrombectomy catheter;

FIG. 4a illustrates an isometric view of a toroidal loop jet emanator;

FIG. 4b illustrates an isometric view of a semi-toroidal loop jetemanator;

FIG. 4c illustrates an isometric view of an L-shaped jet emanator;

FIG. 4d illustrates an isometric view of a J-shaped jet emanator havingjet orifices located on the J-shaped proximal facing surface;

FIG. 4e illustrates an isometric view of a J-shaped jet emanator havinga jet orifice located at the jet emanator extreme end;

FIG. 4f illustrates an isometric view of a J-shaped jet emanator havinga necked-down portion and co-located orifice;

FIG. 4g illustrates an isometric view of a J-shaped jet emanator havingan inserted tubular orifice member;

FIG. 5 illustrates a mode of operation view of the cross streamthrombectomy catheter positioned in a blood vessel, artery or the likeat the site of a thrombotic deposit or lesion;

FIG. 6 illustrates the cross stream of saline jets from the outfloworifice(s) to the inflow orifice(s);

FIG. 7, a first alternative embodiment, illustrates a side view showingthe distal end of an exhaust tube having a single-opening dual-functionorifice;

FIG. 8 illustrates a cross section view of the first alternativeembodiment showing the distal end of the exhaust tube;

FIG. 9, a second alternative embodiment, illustrates a cross sectionview showing the distal end of an exhaust tube having a tip with aproximally facing planar surface and also showing a single-orificeU-shaped jet emanator aligned with an inflow orifice located at the endof the exhaust tube;

FIG. 10 illustrates an end view of the second alternative embodimentshown in FIG. 9;

FIG. 11 illustrates a view of the tip at the distal end of the exhausttube along line 11—11 of FIG. 9;

FIG. 12, a third alternative embodiment, illustrates a cross sectionview showing the distal end of an exhaust tube having a tip with aproximally facing curved surface and also showing a single-orificeU-shaped jet emanator aligned with an inflow orifice located at the endof the exhaust tube;

FIG. 13 illustrates an end view of the third alternative embodimentshown in FIG. 12;

FIG. 14 illustrates a view of the tip at the distal end of the exhausttube along line 14—14 of FIG. 12;

FIG. 15, a fourth alternative embodiment, illustrates a cross sectionview showing the distal end of an exhaust tube and showing a toroidalloop jet emanator aligned to an inflow orifice located at the end of theexhaust tube;

FIG. 16 illustrates an end view of the fourth alternative embodimentshown in FIG. 15;

FIG. 17 illustrates a view of the tip at the distal end of the exhausttube along line 17—17 of FIG. 15;

FIG. 18, a fifth alternative embodiment, illustrates a side view of anelongated device in the form of another cross stream thrombectomycatheter similar to that of FIG. 1, but without exhaust provision; and,

FIG. 19 is a cross section view of the distal end of the cross streamthrombectomy catheter of FIG. 18.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1A illustrates in block diagram form a cross stream thrombectomycatheter system according to one embodiment of the present inventionshowing the interrelation of the various functional means thereof foruse in removing thrombus or other unwanted material from a body vesselor cavity.

The major components of the system include an elongated device in theform of a cross stream thrombectomy catheter, a pressurized fluid sourcemeans, and, optionally, an exhaust regulation means connected to acollection system (not shown).

The elongated device includes first and second tubular means each havinga proximal end and a distal end. The first tubular means is in the formof a high pressure tubular means having pressurized fluid connectionmeans providing a fluid connection permanently or detachably coupled toits proximal end and jet emanator means at its distal end, thepressurized fluid connection means being connectible to the pressurizedfluid source means. The second tubular means is in the form of either anexhaust tubular means, as shown, or other tubular means (not shown inFIG. 1A but described in detail in relation to FIGS. 18 and 19) whichserves as an alternative to an exhaust tubular means in those instanceswhen exhausting is not necessary or desired. When in the form of anexhaust tubular means, the second tubular means is usually associatedwith exhaust regulation means, although an exhaust regulation means isnot essential. Whether in the form of an exhaust tubular means or othertubular means, the second tubular means includes outflow means andinflow means which in concert with high velocity jet(s) produced by thejet emanator means create cross stream jet(s) that establish a flowrecirculation pattern.

The outflow means consists of one or more outflow orifices through whichsaline, blood or other fluid or a mixture thereof with maceratedthrombus or other unwanted material debris flows from a region of higherpressure within the exhaust tubular means or other tubular means tooutside the exhaust tubular means or other tubular means. The outfloworifices(s) are typically somewhat downstream from the high velocityregion of the high velocity jet(s) where the velocities are lower andthe mass flow rate is greater due to entrained fluid; and flow of fluidwith or without macerated debris typically flows through the outfloworifice(s) with a component in the radial direction, creating crossstream jet(s). The outflow orifices may be round, elliptical, conical,slits, gaps between components, or other shape or design.

The inflow means consists of one or more inflow orifices through whichthe high velocity jet(s) draw in by fluid entrainment blood or otherfluid from a body vessel or cavity, including thrombus or other unwantedmaterial which may be present in the blood or other fluid. The infloworifice(s) are typically near the high velocity region of the highvelocity jet(s) where entrainment forces are great. The inflow orificesmay be round, elliptical, conical, slits, gaps between components, orother shape or design.

The high pressure tubular means comprises an elongated structure havingat least one passage or lumen along the length thereof suitable forpassage of high pressure fluid. The elongated structure can be tubingwith a circular or non-circular cross section and can be made of highstrength polymeric material such as polyimide, metallic material such asstainless steel or titanium, or composite material such asfiber-reinforced material or a layered structure composed of layers ofdifferent materials.

The exhaust tubular means comprises an elongated structure having atleast one passage or lumen along the length thereof suitable for passageof fluid and thrombus or other unwanted material debris. The elongatedstructure can be tubing with a circular or non-circular cross sectionand can be made of polymeric material such a polyethylene, polyester,polyurethane, or polyether block amide, high strength polymeric materialsuch as polyimide, metallic material such as stainless steel ortitanium, or composite material such as fiber-reinforced polymericmaterial or a layered structure composed of layers of differentmaterials. Further, the elongated structure may have an attachedstructure near its distal end such as a chamber or manifold toaccommodate the outflow means and the inflow means.

The other tubular means comprises an elongated structure having at leastone passage or lumen along the length thereof suitable for passage offluid. The elongated structure can be tubing with a circular ornon-circular cross section or may resemble a shorter chamber such as amanifold, molded or constructed of multiple components. Suitablematerials for the other tubular means are polymeric material such aspolyethylene, polyester, or polyurethane, high strength polymericmaterial such as polyimide, metallic material such as stainless steel ortitanium, or composite material such as fiber-reinforced polymericmaterial or a layered structure composed of layers of differentmaterials.

If desired, isolation means (not shown) can be provided as part of theelongated device to isolate the region of the body vessel or cavitybeing treated, although this is not always required. Isolation means caninclude balloons, filters, baskets, membranes, blood pressuremodification, fluid flow control, or other occlusion devices such as areknown in the art. Isolation means can limit passage of debris in theblood vessel, limit the flow of blood in the area of the elongateddevice, or confine the recirculation area. Also if desired, additionaltubular means can be provided for communication between the proximal endand the distal end of the elongated device, such as for passage of fluidor other material or for passage of devices such as guidewires,catheters, or imaging tools, or for actuation of isolation means, forinflation of a balloon, or for passage of medication or body fluids. Theadditional tubular means (not shown) comprises an elongated structurehaving at least one passage or lumen along the length thereof; forexample, the elongated device can include a multiple-lumen tube, inwhich one lumen functions as the high pressure tubular means, a secondlumen functions as the exhaust tubular means, and one or more additionallumens function as the additional tubular means which communicatesbetween the proximal and distal ends of the elongated device.

The pressurized fluid source means includes fluid such as saline and oneor more pumps or pressure intensifiers or pressurized fluid containersfor delivering the fluid under pressure to the high pressure tubularmeans through the pressurized fluid connection means coupled to theproximal end thereof. The fluid can be provided at a single pressure orat multiple pressures, at variable or adjustable pressure, and at asteady flow or unsteady flow such as pulsatile flow.

The exhaust regulation means, when present, comprises structuralcomponents which increase, decrease, limit, or adjust the rate of flowof fluid and thrombus or other unwanted material debris along theexhaust tubular means and can be one or more pumps such as roller pumpsor peristaltic pumps, clamps, restrictors, or other devices to influencethe fluid flow rate. The exhaust regulation means can regulate exhaustat a predetermined or user-adjustable flow rate which can be correlatedwith or independent of the rate of flow of the pressurized fluid flowingalong the high pressure tubular means. Further, the exhaust regulationmeans can have pressure measurement or flow rate measurementcapabilities. The exhaust regulation means is connected to a suitablecollection system (not shown).

The system is placed in operation by inserting the elongated device intoa body vessel or cavity and advancing it to a site of thrombus or otherunwanted material in the body vessel or cavity. Then the proximal end ofthe elongated device is connected to the pressurized fluid source meanswhich provides pressurized saline (or other biologically compatiblefluid) to the proximal end of the high pressure tubular means via thepressurized fluid connection means. At the distal end of the highpressure tubular means, pressurized saline (or other fluid) passes intothe jet emanator means which produces high velocity saline (or otherfluid) jet(s). The high velocity saline (or other fluid) jet(s) entrainblood or other fluid from the body vessel or cavity and draw it into thedistal portion of the elongated device through the inflow means,carrying thrombus or other unwanted material from the body vessel orcavity along with the blood or other fluid. The high velocity saline (orother fluid) jet(s) together with the entrained blood or other fluidcreate a region of elevated pressure in the elongated device; thisregion of elevated pressure communicates with or is a part of the distalportion of the exhaust tubular means. The elevated pressure in theelevated pressure region drives fluid flow through the outflow means,creating cross stream jet(s) which have a radial component and may havecircumferential and/or axial component(s) as well. The fluid in theelevated pressure region includes saline (or other fluid) from the highvelocity jet(s) as well as the entrained blood or other fluid from thebody vessel or cavity. The cross stream jet(s) impart normal and dragforces on thrombus or other unwanted material in the body vessel orcavity and greatly improve the effectiveness of the device in removingand breaking apart thrombus or other unwanted material which may beadhered to the body vessel or cavity, and form a recirculation patternwhich further aids in drawing thrombus or other unwanted materialtowards the inflow means. The combination of outflow means, cross streamjet(s), recirculation pattern, inflow means, and high velocity jet(s)synergistically acts to provide for enhanced breakup and removal ofthrombus or other unwanted material. The elevated pressure in theelevated pressure region can also aid in the transport of fluid andthrombus or other unwanted material debris through the exhaust tubularmeans. If desired, the rate of flow of fluid and thrombus or otherunwanted material regulated by providing exhaust regulation means,although this is not always required.

FIG. 1B illustrates a side view of an elongated device in the form of across stream thrombectomy catheter with exhaust provision 10 useful forthe removal of thrombus. Externally visible components, or portions ofcomponents, of the cross stream thrombectomy catheter 10 include amanifold 12, a hemostasis unit 14 secured in the proximal end of themanifold 12, pressurized fluid connection means in the form of athreaded high pressure connection 11 and a Luer fitting 16 located atthe proximal end of an angled manifold branch 18 extending from themanifold 12 for coupling to the pressurized fluid source means, a Luerconnection 20 for coupling to exhaust regulation means located at theproximal end of another angled manifold branch 22 extending from themanifold branch 18, a Luer fitting 24 secured to the distal end of themanifold 12, a strain relief 26 secured to the distal end of themanifold 12 by the Luer fitting 24, exhaust tubular means in the form ofan exhaust tube 28 having a proximal end 30 secured to the manifold 12by the strain relief 26 and Luer fitting 24, outflow means in the formof one or more distally located outflow orifices 32 at the distal end 38of the exhaust tube 28, inflow means in the form of one or more distallylocated inflow orifices 34 at the distal end 38 of the exhaust tube 28,and a tapered and flexible tip assembly 36 located at and aligned to andattached, as later described and illustrated, to the distal end of a jetemanator means in the form of a toroidal loop jet emanator residing inas well as being attached to the distal end 38 of the exhaust tube 28.

FIGS. 2 and 3 illustrate an exploded view and an assembled view in crosssection of the distal end 38 and other distally located components ofthe cross stream thrombectomy catheter 10, respectively, where allnumerals mentioned before correspond to those elements previouslydescribed. The primary two components of the cross stream thrombectomycatheter 10 are first and second tubular means, the first being a highpressure tubular means made of metal or high tensile strength polymer orcomposite material and shown in the form of a hypo-tube 44 formed into ajet body 40, and the second being in the form of an exhaust tubularmeans made of a flexible polymer and shown in the form of an exhausttube 28 having a centrally located exhaust lumen 42. The jet body 40 isformed from a small hypo-tube 44 with a size range of 0.010 to 0.030inch outer diameter. The distal portion of the hypo-tube 44 may bereduced to a small diameter as shown by reduction 43 (FIG. 2) to makethe catheter more flexible by drawing the hypo-tube 44 through a die.The distal end of the hypo-tube 44 is then welded shut and the endformed into a toroidal loop jet emanator 46 or a jet emanator of othershape which will provide a surface in which proximally directed jetorifices 60 a-60 n (FIG. 4a), ranging from 0.001 to 0.010 inch indiameter, may be formed that will direct jetted saline or otherbody-compatible solution including mixtures of saline and medications ormixtures of saline and a contrast medium in a flow at or close to a pathparallel to and in the opposite direction of the fluid flow in theinterior of the hypo-tube 44 of the jet body 40. Alternatively, the jetbody 40 may be of a short length and connected to a more flexiblepolymeric tube 45 (FIG. 3) in lieu of having a jet body 40 which extendsproximally for the majority of the distance to the manifold 12. Aradio-opaque marker coil 48 in the form of a stainless steel or platinumalloy coil, for example, may be adhered to the end of the jet body 40and other components, as later described in detail.

The jet body 40, which has a smaller axial profile than that of theexhaust lumen 42, is inserted through and located within the exhaustlumen 42. The exhaust lumen 42 is central to the exhaust tube 28, whichcould also have multiple lumens, which has an outer diameter rangingfrom 0.030 to 0.150 inch, and which is also flexible and similar to thehypo-tube 44 in that it may be reduced to a smaller diameter to make thecatheter more flexible by drawing through a die. The tapered andflexible tip assembly 36 includes a flexible plastic tapered tube 37which encapsulates and surrounds the radio-opaque marker coil 48, whichhas a closely wound portion 54 and a loosely wound portion 56.Alternatively, the radio-opaque marker coil 48 can have uniform windspacing, or can be omitted in favor of a polymeric tip.

A mechanical bond can be made between the distal tip of the jet body 40at the junction of the toroidal loop jet emanator 46 and the exhaustlumen 42. For example, thermal and partial melting of the tapered distaltip 52 of the polymer exhaust tube 28 partially encapsulates thetoroidal loop jet emanator 46 or other distal shape of the jet body 40.Thermal melting can also be incorporated to join the interior wall 57 ofthe exhaust tube 28 to the proximal area 59 of the tapered tube 37whereby further heat transfer and melting can also encapsulate and jointhe closely wound portion 54 and the loosely wound portion 56 of theradio-opaque marker coil 48 to the interior wall 58 of the tapered tube37. In the alternative, an adhesive can also be incorporated to join thetoroidal loop jet emanator 46 to the interior of the exhaust tube 28 andto the proximal portion of the closely wound spring portion 54 and tothe proximal area 59 of the tapered tube 37. Multiple inflow and outfloworifices can be formed anywhere as desired along the length of exhausttube 28, either before or after the loading of the jet body 40,preferably in the distal portion, which as described below includesinflow and outflow orifices 34 and 32, respectively. Although thepreferred embodiment of the catheter is made with multiple outflow andinflow orifices 32 and 34, a substantially equivalent catheter could bedesigned such that the catheter has only one extended orifice, butseparate regions in that one orifice provide inflow and outflow offluid. Preferably, the inflow and outflow orifices 34 and 32 are oval orround in shape, but they can be of other suitable geometricconfiguration or shape.

FIGS. 4a through 4 g illustrate jet emanator means which may be utilizedat the end of and which are located at the distal end of the jet body40, each of which directs high velocity jet streams proximally along ornear the longitudinal axis of the jet body 40 and the exhaust tube 28.Each jet emanator means comprises a tubular structure through whichpressurized fluid flows creating high velocity fluid jets which emanatefrom one or more orifices in the tubular structure. The tubularstructure can be of straight, curved, L-shaped, J-shaped, U-shaped,helical, toroidal or semi-toroidal shape, or can be a chamber such as amanifold, and may be formed of a single component, such as a metalhypo-tube, or of multiple components, such as multiple hypo-tubes,welded manifold components, or molded manifold components. The tubularstructure forming the jet emanator means may be formed as a unitary partof the high pressure tubular means such as by forming a metal hypo-tubeinto a toroidal shape, or one of the other shapes mentioned above, witha single orifice or multiple orifices produced by drilling or cutting.The orifices can be round, slits, or other shapes so that fluid flowingtherethrough forms one or more discrete high velocity fluid jets ormerges into combination jets. Alternatively, the tubular structureforming the jet emanator means may be a separate structure having anyone of the aforementioned shapes and orifice constructions which isattached to the distal end of the high pressure tubular means. In eitherevent, the tubular structure forming the jet emanator means is in fluidcommunication with the high pressure tubular means. In each figure,highly pressurized fluid(s) first passes through a lumen 41 enroute tothe variously shaped and configured distally located jet emanator meanslocated at the end of the jet body 40.

FIG. 4a illustrates an isometric view of the toroidal loop jet emanator46, one jet emanator means of which may be utilized at the end of andwhich is located at the distal end of the jet body 40, where allnumerals mentioned before correspond to those elements previouslydescribed. Illustrated in particular are the plurality of proximallydirected jet orifices 60 a-60 n located on the proximal surface of thetoroidal loop jet emanator 46 which direct high velocity jet streamsproximally, as shown by dashed lines, along or near the longitudinalaxis of the jet body 40 and the exhaust tube 28. The toroidal loop jetemanator 46 includes a circular space 50 along the inner circumferenceto provide for and to accommodate alignment of and for passage along aguidewire, such as the guidewire 51 shown partially in FIG. 5. Multiplejet orifices 60 a-60 n located at points along the toroidal loop jetemanator 46 can advantageously direct high velocity jet streams onmultiple sides of the guidewire 51 when it is positioned in the circularspace 50 to avoid having guidewire 51 block inflow orifice(s) 34 oroutflow orifice(s) 32 which could hamper the recirculation pattern, suchas that shown in FIGS. 5 and 6.

FIG. 4b illustrates an isometric view of a semi-toroidal loop jetemanator 62, another jet emanator means of which may be utilized at theend of and which is located at the distal end of the jet body 40, whereall numerals mentioned before correspond to those elements previouslydescribed. Illustrated in particular are the plurality of proximallydirected jet orifices 64 a-64 n located on the proximal surface of thesemi-toroidal loop jet emanator 62 which direct high velocity jetstreams proximally, as shown by dashed lines, along or near thelongitudinal axis of the jet body 40 and the exhaust tube 28. Thesemi-toroidal loop jet emanator 62 includes a semi-circular space 66along the inner circumference to provide for and to accommodatealignment of and for passage along a guidewire.

FIG. 4c illustrates an isometric view of an L-shaped jet emanator 68,another jet emanator means of which may be utilized at the end of andwhich is located at the distal end of the jet body 40, where allnumerals mentioned before correspond to those elements previouslydescribed. Illustrated in particular is a proximally directed jetorifice 70 located on the proximal surface of the L-shaped jet emanator68 which directs a high velocity jet stream proximally, as shown by adashed line, along or near the longitudinal axis of the jet body 40 andthe exhaust tube 28.

FIG. 4d illustrates an isometric view of a J-shaped jet emanator 72having jet orifices located on the J-shaped proximal facing curvedsurface, another jet emanator means of which may be utilized at the endof and which is located at the distal end of the jet body 40, where allnumerals mentioned before correspond to those elements previouslydescribed. The J-shaped jet emanator 72 and the jet body 40 andhypo-tube 44 align in a common plane. Illustrated in particular is aplurality of proximally directed jet orifices 74 a-74 n located on theproximal curved surface of the J-shaped jet emanator 72 which directhigh velocity jet streams proximally, as shown by dashed lines, along ornear the longitudinal axis of the jet body 40 and the exhaust tube 28.

FIG. 4e illustrates an isometric view of a J-shaped jet emanator 75having a jet orifice located at the emanator end, being another jetemanator means of which may be utilized at the end of and which islocated at the distal end of the jet body 40, where all numeralsmentioned before correspond to those elements previously described. TheJ-shaped jet emanator 75 and the jet body 40 and hypo-tube 44 align in acommon plane. Illustrated in particular is a proximally directed jetorifice 77 located at the extreme end 79 of the J-shaped jet emanator 75which directs a high velocity jet stream proximally, as shown by adashed line, along or near the longitudinal axis of the jet body 40 andthe exhaust tube 28. The extreme end 79 preferably is first welded shutto form a dome or other suitably shaped structure which is drilled orbored to form the appropriately sized jet orifice 77.

FIG. 4f illustrates an isometric view of a J-shaped jet emanator 81having a necked-down region and co-located orifice, another jet emanatormeans of which may be utilized at the end of and which is located at thedistal end of the jet body 40, where all numerals mentioned beforecorrespond to those elements previously described. The J-shaped jetemanator 81 and the jet body 40 and hypo-tube 44 and a necked-downportion 89 align in a common plane. Illustrated in particular is aproximally directed jet orifice 83 located at the extreme end 87 of thenecked-down portion 89 of the J-shaped jet emanator 81 which directs ahigh velocity jet stream proximally, as shown by a dashed line, along ornear the longitudinal axis of the jet body 40 and the exhaust tube 28.The necked-down portion 89 is appropriately drawn, formed and/or sizedto produce an appropriately sized jet orifice 83.

FIG. 4g illustrates an isometric view of a J-shaped jet emanator 91having an inserted tubular orifice member, another jet emanator means ofwhich may be utilized at the end of and which is located at the distalend of the jet body 40, where all numerals mentioned before correspondto those elements previously described. The J-shaped jet emanator 91 andthe jet body 40 and hypo-tube 44 align in a common plane. The J-shapedjet emanator 91 includes a housing 93 which is part of and which extendsproximally from the curved region of the J-shaped jet emanator 91. Thehousing 93 accommodates within an appropriately sized tubular orificemember 95 which directs a high velocity jet stream proximally, as shownby a dashed line, along or near the longitudinal axis of the jet body 40and the exhaust tube 28.

MODE OF OPERATION

FIG. 5 illustrates in cross section a mode of operation view of thecross stream thrombectomy catheter 10 with particular attention to thedistal end 38 of the exhaust tube 28 positioned in a blood vessel 76,artery or the like at the site of a thrombotic deposit or lesion 78.High velocity jets 80 of saline (or other suitable fluid) are shownbeing emitted in a proximal direction from the toroidal loop jetemanator 46. The semi-toroidal loop jet emanator 62 of FIG. 4b, L-shapedjet emanator 68 of FIG. 4c, the J-shaped jet emanator 72 of FIG. 4d, theJ-shaped jet emanator 75 of FIG. 4e, the J-shaped jet emanator 81 ofFIG. 4f, or the J-shaped emanator 91 of FIG. 4g can be incorporated atthe distal portion of the jet body 40, as well as and as an alternativeto the toroidal loop jet emanator 46 illustrated in this figure, toemanate or emit one or more high velocity jets 80 distally along or nearthe longitudinal axis of the jet body 40 and the exhaust tube 28. Thesaline fluid of jet(s) 80 passes outwardly through the outfloworifice(s) 32 in a radial direction creating cross stream jet(s) 82(lower velocity jet(s)) directed outwardly toward the wall of the bloodvessel 76 and are influenced by the low pressure at the infloworifice(s) 34 to cause the cross stream jet(s) 82 to flowcircumferentially and distally to impinge on, provide drag forces on,and break up thrombotic deposits or lesions 78 and to, by entrainment,urge and carry along the particles of thrombotic deposits or lesions 78through the inflow orifice(s) 34, a relatively low pressure region, andinto the exhaust lumen 42. The entrainment through the inflow orifice(s)34 is based on entrainment by the high velocity jet(s) 80. The outflowis driven by internal pressure which is created by the high velocityjet(s) 80 and the fluid entrained through the inflow orifice(s) 34. Theenhanced clot removal is because of the recirculation patternestablished between inflow and outflow orifices 34 and 32, which createsa flow field that maximizes drag force on wall-adhered thrombus.

FIG. 6 illustrates in cross section the mode of operation viewillustrating the cross stream jet(s) 82 (or stream(s)) and therecirculation pattern. For the purpose of clarity, the illustrationshows the outflow orifice(s) 32 and the inflow orifice(s) 34 at the samestation along the exhaust tube 28. Shown in particular is the flow ofthe cross stream jet(s) 82 which flow outwardly in radial fashion fromthe outflow orifice(s) 32 to impinge thrombotic deposits or lesions 78and to urge and carry macerated thrombotic deposits or lesion particles78 to the inflow orifice(s) 34 where the particles of thromboticdeposits or lesions 78 are entrained by the high velocity jet(s) 80 (notshown) and carried away through the exhaust lumen 42. Circumferentialflow occurs along and substantially parallel to the inner boundary ofthe blood vessel 76 in a direction leading to the inflow orifice(s) 34.

MODE OF OPERATION

A manifold is attached to the tubular assembly on the proximal end toallow connection of the hypo-tube 44 of the jet body 40 to a 10 to 200cc/min supply of saline (or other suitable fluid) at a back pressure inthe range of approximately 150 psi to 50,000 psi, and to allowconnection of exhaust lumen 42 to tubing attached to a collectionsystem, preferably with exhaust regulation means involved to control thelevel of the exhaust. Suitable specific pressure ranges for the supplyfluid can be approximately 150-500 psi, approximately 500-2,500 psi, orapproximately 2,500-50,000 psi, depending on the particular situationinvolved.

The catheter is operated by injection with the high pressure salinesupply through the threaded high pressure connection 11. The salineflows through the jet body 40 and into the jet emanator means wherein,depending on the supply pressure, it exists in pressure ranges ofapproximately 50-350 psi, 350-850 psi, or 850-35,000 psi. The salineexits the jet orifice(s) 60 a-60 n at a maximum instantaneous centerlinevelocity of approximately 2,000 to 30,000 cm/s, preferably 7,000 cm/s to20,000 cm/s, and passes near at least one of the inflow orifice(s) 34 ofthe exhaust lumen 42. Since the catheter is operated in liquid mediawithin the body, the saline jet(s) 80 behave as submerged jet(s) in thattheir momentum is transferred to the surrounding fluid, a phenomenaknown as entrainment. Due to the geometry of the catheter, the entrainedfluid is brought into the inflow orifice(s) 34 in flow rates of 1 to 20times that of the high velocity saline exiting the jet orifices 60 a-60n.

Once entrained fluid has entered the inflow orifice(s) 34, the fluidwill take the path of least resistance to exit the catheter. If thecatheter were made with no outflow orifice(s) 32 and the exhaust lumenhad no hydrodynamic resistance, all the entrained fluid would beexhausted out of the body through the exhaust lumen 42 and into thecollection system. However, if there is significant amount ofhydrodynamic resistance, either through pipe flow resistance in theexhaust lumen 42 or an exhaust regulation means, not all of theentrained fluid can be exhausted from the catheter. If there were nooutflow orifice(s) 32 in the catheter, at least a portion of the infloworifice(s) 34 will have fluid transported out of the catheter in orderto maintain a mass balance of fluid in the catheter (all components ofthe catheter are incompressible or inelastic so that there is noaccumulation of mass in the catheter).

The incorporation of outflow orifice(s) 32 in the catheter allowsmaintenance of the mass balance at the tip of the catheter without arequirement that a portion of the inflow orifice(s) 34 will have fluidtransported out of the catheter. The benefit of removing thetwo-directional flow through the inflow orifice(s) 34 is that frictionbetween the entrained fluid and fluid that is being transported out ofthe catheter has been eliminated. Thus, both of these flows will beincreased by having the outflow orifice(s) 32 incorporated into thecatheter to act to greatly enhance the thrombectomy effect of thecatheter on organized mural thrombus.

FIGS. 7 and 8 illustrate a side view and a cross section view,respectively, of a first alternative embodiment showing distal end 84 ofthe exhaust tube 28 which can be incorporated into use with the firstembodiment of and for use with the majority of the components of thecross stream thrombectomy catheter previously described, where allnumerals mentioned before correspond to those elements previouslydescribed. Although the preferred embodiment of the catheter includesmultiple outflow and inflow orifices 32 and 34, a substantiallyequivalent catheter having one or more single opening dual functionorifices 85 can be provided, each orifice 85 having separate regionssuch that one single opening orifice provides for inflow and outflow offluid. Preferably, the orifice 85 is an elongated shape, but can be ofother suitable geometric configuration or shape. FIG. 7 illustrates anelongated and tapered orifice 85 having at one end a semi-circulardistally located radiused inflow end 86 corresponding to the infloworifice 34 and a semi-circular proximally located relatively smallerradiused outflow end 88 corresponding to the outflow orifice 32 opposingthe radiused inflow end 86. A cross stream thrombectomy catheterincorporating the distal end 84 of the exhaust tube 28 operatesaccording to the teachings of the invention with the benefit of simplerand more easily accomplished construction which combines the inflow andoutflow orifices into a single opening orifice. Although toroidal loopjet emanator 46 is shown in the embodiment, other jet emanators such thesemi-toroidal loop jet emanator 62 of FIG. 4b, the L-shaped jet emanator68 of FIG. 4c, the J-shaped jet emanator 72 of FIG. 4d, the J-shaped jetemanator 75 of FIG. 4e, the J-shaped jet emanator 81 of FIG. 4f, or theJ-shaped jet emanator 91 of FIG. 4g, or other such suitable jet emanatoror device can be incorporated into use with this embodiment of thepresent invention. Flow of the cross stream jet(s) 82 is illustrated inFIG. 7.

FIGS. 9 through 17 illustrate second, third and fourth alternativeembodiments of distal ends of the exhaust tube 28 where the infloworifices are located at the extreme end of the exhaust lumen 42 of theexhaust tube 28 as an alternative to inflow orifice placement on thesidewall of the exhaust tube 28 as previously described, and where useof the tapered and flexible tip assembly 36 is not required. The distalends are assigned different designator number references in allowancefor differently located inflow or outflow orifices or other variances orcombinations thereof at or near the distal ends.

FIGS. 9 and 10, illustrate a cross section view and an end view,respectively, of a second alternative embodiment showing distal end 90of the exhaust tube 28 which can be incorporated into use with themanifold 12, the jet body 40 and the exhaust tube 28 with the exceptionof the tapered and flexible tip assembly 36 of the first embodiment andis intended for use with the majority of the components of the crossstream thrombectomy catheter previously described, where all numeralsmentioned before correspond to those elements previously described. Atip 92 is located at or near the distal end of the jet body 40 and atthe distal end 90 of the exhaust tube 28. The tip 92, which can be ofmetallic, polymeric or other suitable material, aligns and suitablysecures to the distal end 90 of the exhaust tube 28. The tip 92 includesa bore 94 which supports the jet body 40. The jet body 40 extendsdistally beyond the bore 94 of the tip 92 and forms a U-shaped jetemanator 96 having a single centrally located jet orifice 98, which isthe end of the lumen 41 of the extended jet body 40 making up theU-shaped jet emanator 96. The jet orifice 98 of the U-shaped jetemanator 96 is directed at an inflow orifice 100 aligned longitudinallyand located in the tip 92. A high velocity jet 102 of saline is emittedin a proximal direction from the jet orifice 98 and through the infloworifice 100. Fluid is entrained by the high velocity jet 102 and isthereby drawn through the inflow orifice 100 and driven into the exhaustlumen 42 and mixes with saline from the high velocity jet 102. Part ofthis entrained fluid mixed with the saline from the high velocity jet102 passes outwardly through the outflow orifice 104 in a radialdirection creating a cross stream jet 106 (lower velocity jet) directedoutwardly toward the wall of a blood vessel and is influenced by the lowpressure at the inflow orifice 100 to cause the cross stream jet 106 toflow circumferentially and distally to impinge on, provide drag forceson, and break up thrombotic deposits or lesions and to, by entrainment,urge and carry along the thrombotic deposits or lesions through theinflow orifice 100, a relatively low pressure region, and into theexhaust lumen 42. The flow of fluid and thrombotic deposits through theinflow orifice 100 is based on entrainment by the high velocity jet 102.The outflow through outflow orifice 104 is driven by internal pressurewhich is created by the high velocity jet 102 and the fluid entrainedthrough the inflow orifice 100. The enhanced clot removal is because ofthe recirculation pattern established between inflow and outfloworifices 100 and 104, which creates a flow field that maximizes dragforce on wall-adhered thrombus. Although a U-shaped jet emanator 96 isshown in the embodiment, other jet emanators such as the semi-toroidalloop jet emanator 62 of FIG. 4b, the L-shaped jet emanator 68 of FIG.4c, the J-shaped jet emanator 72 of FIG. 4d, the J-shaped jet emanator75 of FIG. 4e, the J-shaped jet emanator 81 of FIG. 4f, or the J-shapedjet emanator 91 of FIG. 4g, or other such suitable jet emanator ordevice can be incorporated into use with this embodiment of the presentinvention.

FIG. 11 illustrates a view of the tip 92 along line 11—11 of FIG. 9,where all numerals correspond to those elements previously described.

FIGS. 12 and 13 illustrate a cross section view and an end view,respectively, of a third alternative embodiment which operates accordingto the teachings of the invention, and more specifically, according tothe teachings of FIGS. 9, 10 and 11 and which incorporates many of thecomponents shown in FIGS. 9, 10 and 11. FIGS. 12 and 13 illustrate a tip108 having similarities to tip 92 of FIG. 9, but including an inwardlyor proximally facing curved surface 112. The curved surface 112 assistsand promotes alignment of a guidewire through an inflow orifice 110 ofthe tip 108. The distal end 114 of the exhaust tube 28 including the tip108 can be incorporated into use with the manifold 12, the jet body 40and the exhaust tube 28 with the exception of the tapered and flexibletip assembly 36 of the first embodiment and is intended for use with themajority of the components of the cross stream thrombectomy catheterpreviously described, where all numerals mentioned before correspond tothose elements previously described. The tip 108 is located at or nearthe distal end of the jet body 40 and at the distal end 114 of theexhaust tube 28. The tip 108, which can be of metallic, polymeric orother suitable material, aligns and suitably secures to the distal end114 of the exhaust tube 28. The tip 108 includes a bore 115 whichsupports the jet body 40. As previously described, the jet body 40extends distally beyond the bore 115 of the tip 108 to form the U-shapedjet emanator 96 having a single centrally located jet orifice 98 whichis the end of the lumen 41 of the extended jet body 40 making up theU-shaped jet emanator 96. The jet orifice 98 of the U-shaped jetemanator 96 is directed at an inflow orifice 110 aligned longitudinallyand located in the tip 108. A high velocity jet 118 of saline is emittedin a proximal direction from the jet orifice 98 and through the infloworifice 110 to operate in a manner and fashion such as described forFIGS. 9, 10 and 11. Although U-shaped jet emanator 96 is shown in theembodiment, other jet emanators such as the toroidal loop jet emanator46 of FIG. 4a, the semi-toroidal loop jet emanator 62 of FIG. 4b, theL-shaped jet emanator 68 of FIG. 4c, the J-shaped jet emanator 72 ofFIG. 4d, the J-shaped jet emanator 75 of FIG. 4e, the J-shaped jetemanator 81 of FIG. 4f, the J-shaped jet emanator 91 of FIG. 4g, orother such suitable jet emanator or device can be incorporated into usewith this embodiment of the present invention.

FIG. 14 illustrates a view of the tip 108 along line 14—14 of FIG. 12,where all numerals correspond to those elements previously described.

FIGS. 15 and 16 illustrate a cross section view and an end view,respectively, of a fourth alternative embodiment showing distal end 122of the exhaust tube 28 which can be incorporated into use with themanifold 12, the jet body 40 and the exhaust tube 28 with the exceptionof the tapered and flexible tip assembly 36 of the first embodiment andis intended for use with the majority of the components of the crossstream thrombectomy catheter previously described, where all numeralsmentioned before correspond to those elements previously described. Atip 124 is located at or near the distal end of the jet body 40 and atthe distal end 122 of the exhaust tube 28. The tip 124, which can be ofmetallic, polymeric or other suitable material, aligns and suitablysecures to the distal end 122 of the exhaust tube 28. The tip 124includes a bore 126 which supports the jet body 40. The jet body 40extends distally beyond the bore 126 of the tip 124 and forms a toroidalloop jet emanator 128 having a plurality of proximally directed jetorifices 130 a-130 n. The jet orifices 130 a-130 n of the toroidal loopjet emanator 128 are directed at an inflow orifice 132 alignedlongitudinally and located in the tip 124. The high velocity jets 134a-134 n of saline are emitted in a proximal direction from the jetorifices 130 a-130 n and through the inflow orifice 132. Fluid, such asblood and thrombotic debris which may be near the tip 124, is entrainedby the high velocity jets 134 a-134 n and is thereby drawn throughinflow orifice 132 and acts in a manner and fashion such as describedfor FIGS. 9, 10 and 11, such that cross stream jets 106 andrecirculation pattern between the outflow orifice 104 and the infloworifice 132 synergistically enhances thrombus removal.

FIG. 17 illustrates a view of the tip 124 along line 17—17 of FIG. 15,where all numerals mentioned before correspond to those elementspreviously described. A circular space 136 along the inner circumferenceof the toroidal loop jet emanator 128 is provided to accommodatealignment and passage along a guidewire.

FIG. 18, a fifth alternative embodiment, illustrates a side view of across stream thrombectomy catheter 10A which is similar to the crossstream thrombectomy catheter 10 of FIG. 1B but without exhaustprovision, and therefore does not include the manifold branch 22 andLuer connection 20 which extend from manifold branch 18. Also, in thisfifth alternative embodiment the toroidal loop jet emanator of the FIG.1B embodiment is not employed, and since no exhaust provision ispresent, the second tubular means characterized by the exhaust tubularmeans in the form of the exhaust tube 28 of the FIG. 1B embodiment ischaracterized by other tubular means in the form of a tube 137 which issimilar to the exhaust tube 28 of the FIG. 1B embodiment but which has adistal end 138 of different construction from that of the distal end 38of the embodiment of FIG. 1B. Devices of the fifth alternativeembodiment operate and function similarly to those of the FIG. 1Bembodiment in that a recirculation pattern from outflow orifices 34 toinflow orifices 32 synergistically enhance clot breakup; however, thisembodiment does not provide for removal of the thrombus debris throughthe catheter itself. If desired, thrombus debris can be removed from thebody by separate means, such as a separate catheter or by chemicalmethods. In many cases, such thrombus debris removal would not benecessary since the enhanced clot breakup action of the device producessmall debris which can be left in the body.

FIG. 19 depicts a cross section view of the distal end 138 of the tube137. All numerals appearing in FIGS. 18 and 19 which have been mentionedbefore correspond to those elements previously described. Preferably,hypo-tube 44 is formed into jet body 140 which directs a single highvelocity jet 142 distally past inflow orifice 34. Alternatively, jetbody 140 may be of a short length and connected to a more flexiblepolymeric tube similar to polymeric tube 45 of FIG. 3. Fluid, such asblood and thrombotic debris which may be near distal end 138, isentrained by the high velocity jet 142 and is thereby drawn throughinflow orifice 34. The fluid mixes with saline from the high velocityjet 142, and thrombus is broken apart and pulverized by the highvelocity jet 142. The fluid mixed with saline from high velocity jet 142creates an internal pressure near outflow orifice 32, which createscross stream jet(s) 82 and a recirculation pattern, as indicated, fromoutflow orifice 32 to inflow orifice 34. The recirculation patternincludes radial and circumferential flow vectors, and can include axialflow vectors as well. The recirculation pattern creates a flow fieldthat maximizes force on wall-adhered thrombus or lesion. A guidewire 144is shown passing through the tapered and flexible tip assembly 36 andthrough the tube lumen 143. This fifth alternative embodiment of thepresent invention is similar in many respects to the other embodiments,but does not provide for thrombus debris removal out of the body throughthe catheter. In this embodiment, the key features of inflow/outfloworifices and recirculation allow thrombus to be pulled into the highvelocity jet(s) and to be broken up sufficiently so that they can passdownstream in the blood vessel without significant emboliccomplications. The recirculation can provide for repeated passage ofthrombus fragments into the high velocity jets(s) so that maceration ofthe thrombus can occur. This embodiment may be particularly useful intreating venous thrombus or arteriovenous graft thrombosis, as examples,where moderately small thrombus fragment embolization is less likely tobe of concern. In other situations, isolation means can be incorporatedto prevent significant embolization. This embodiment has certainadvantages over others, in that jet body 140 is simpler to fabricate,smaller in overall diameter, and less expensive than the more complexconfigurations, and the manifold 12 of FIG. 18 is simpler and lessexpensive than that shown in FIG. 1B. Also, since there is norequirement for removal of debris through the catheter, tube 137 of FIG.18 can be a smaller diameter than exhaust tube 28 of FIG. 1B. Theresulting device can then be a smaller diameter and less stiff, whichoffers advantages in allowing a smaller access for inserting thecatheter into a patient and advancing it to the location of thethrombus. While the simple, single-jet jet body 140 is preferred in thefifth alternative embodiment, multiple jets and multiple inflow andoutflow orifices can be used. For example, a jet body configurationsimilar to the semi-toroidal loop jet emanator 62 of FIG. 4b could beused, provided that multiple jet orifices direct fluid jets distallypast one or more inflow orifices. Multiple outflow orifices could beused as well, positioned farther from the jet(s) than the infloworifice(s), or combination inflow/outflow orifice(s) similar toorifice(s) 85 of FIGS. 7 and 8 could be utilized.

THROMBECTOMY CATHETER AND SYSTEM PARTS LIST

10 cross stream thrombectomy catheter

10A cross stream thrombectomy catheter

11 threaded high pressure connection

12 manifold

14 hemostasis unit

16 Luer fitting

18 manifold branch

20 Luer connection

22 manifold branch

24 Luer fitting

26 strain relief

28 exhaust tube

30 proximal end

32 outflow orifice

34 inflow orifice

36 tapered and flexible tip assembly

37 tapered tube

38 distal end

40 jet body

41 lumen

42 exhaust lumen

43 reduction

44 hypo-tube

45 polymeric tube

46 toroidal loop jet emanator

48 marker coil

50 circular space

51 guidewire

52 distal tip (of exhaust tube)

54 closely wound portion

56 loosely wound portion

57 interior wall

58 interior wall

59 proximal area

60 a-n jet orifices

62 semi-toroidal loop jet emanator

64 a-n jet orifices

66 semi-circular space

68 L-shaped jet emanator

70 jet orifice

72 J-shaped jet emanator

74 a-n jet orifices

75 J-shaped jet emanator

76 blood vessel

77 jet orifice

78 thrombotic

79 extreme end

80 high velocity jets

81 J-shaped jet emanator

82 cross stream jets

83 jet orifice

84 distal end

85 orifice

86 inflow end

87 extreme end

88 outflow end

89 necked-down portion

90 distal end

91 J-shaped jet emanator

92 tip

93 housing

94 bore

95 orifice member

96 U-shaped jet emanator

98 jet orifice deposit or lesion

100 inflow orifice

102 high velocity jet

104 outflow orifice

106 cross stream jet

108 tip

110 inflow orifice

112 curved surface

114 distal end

115 bore

118 high velocity jet

122 distal end

124 tip

126 bore

128 toroidal loop jet emanator

130 a-n jet orifices

132 inflow orifice

134 a-n high velocity jets

136 circular space

137 tube

138 distal end

140 jet body

142 jet

143 lumen

144 guidewire

Various modifications can be made to the present invention withoutdeparting from the apparent scope hereof.

It is claimed:
 1. A method of macerating thrombus or other unwantedmaterial in a body vessel or cavity, comprising the steps of: a.providing an elongated device having a first tube residing within andextending along the length of a second tube, said first tube having atits distal end jet emanator means for directing at least one highvelocity fluid jet, inflow means for passage of entrained blood or otherfluid from the body vessel into said second tube, outflow means forpassage of fluid and entrained blood or other fluid from said secondtube into the body vessel, said jet emanator means oriented so that atleast one of said high velocity fluid jet(s) entrains and drawssurrounding blood or other fluid from the body vessel or cavity throughsaid inflow means and into said second tube, and said jet emanator meanslocated with respect to said outflow means such that at least some fluiddirected by said jet emanator means passes through said at least oneoutflow means; b. inserting said elongated device into a body vessel orcavity, and advancing said elongated device to a site of thrombus orother unwanted material in the body vessel or cavity; c. connecting saidelongated device to a source of pressurized fluid so that fluid jet(s)emanate from said jet emanator means, entrains blood or other fluidwhich may contain thrombus or other unwanted material and draws theblood or other fluid into said second tube through said inflow means,and creates a pressurized region in said second tuba which drives fluidand entrained blood or other fluid which may contain thrombus or otherunwanted material out of said second tube through said outflow meanscreating cross stream jet(s) of fluid and entrained blood or otherfluid; and, d. using said elongated device to break apart thrombus orother unwanted material in the body vessel or cavity, where fluid forcesfrom the cross stream jet(s) and a recirculation of fluid from saidoutflow means and back in through said inflow means and past said highvelocity jet (s) macerates said thrombus or other unwanted material. 2.The method of claim 1, wherein said jet emanator means directs at leastone of said high velocity fluid jet(s) towards said inflow means andsaid outflow means.
 3. A method of macerating thrombus or other unwantedmaterial in a body vessel or cavity, comprising the steps of: a.providing an elongated device having a first tube residing within andextending along the length of a second tube, said first tube having atits distal end jet emanator means for directing at least one highvelocity fluid jet, inflow means for passage of entrained blood or otherfluid from the body vessel into said device second tube, outflow meansfor passage of fluid and entrained blood or other fluid from said secondtube into the body vessel, said jet emanator means oriented so that atleast one of said high velocity fluid jet(s) entrains and drawssurrounding blood or other fluid from the body vessel or cavity throughsaid inflow means and into said second tube, and said jet emanator meanslocated with respect to said outflow means such that at least some fluiddirected by said jet emanator means passes through said at least oneoutflow means; b. inserting said elongated device into a body vessel orcavity, and advancing said elongated device to a site of thrombus orother unwanted material in the body vessel or cavity; c. connecting saidelongated device to a source of pressurized fluid so that fluid jet(s)emanate from said jet emanator means, entrains blood or other fluidwhich may contain thrombus or other unwanted material and draws theblood or other fluid into said second tube through said inflow means,and creates a pressurized region in said second tube which drives fluidand entrained blood or other fluid which may contain thrombus or otherunwanted material out of said second-tube through said outflow meanscreating cross stream jet(s) of fluid and entrained blood or otherfluid; d. using said elongated device to break apart thrombus or otherunwanted material in the body vessel or cavity, where fluid forces fromthe cross stream jet(s) and a recirculation of fluid from said outflowmeans and back in through said inflow means and past said high velocityjet(s) macerates said thrombus or other unwanted material; and, e. usingsaid elongated device to remove thrombus or other unwanted material fromthe body.
 4. The method of claim 3, wherein said jet emanator meansdirects at least one of said high velocity fluid jet(s) towards saidinflow means and said outflow means.